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Clinical Trials/NCT04181437
NCT04181437
Completed
Phase 1

A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 in Healthy Adult Subjects

NVP Healthcare1 site in 1 country40 target enrollmentMay 1, 2020

Overview

Phase
Phase 1
Intervention
NVP-1203-R1 and NVP-1203-R2
Conditions
Healthy
Sponsor
NVP Healthcare
Enrollment
40
Locations
1
Primary Endpoint
Pharmacokinetic interaction
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Detailed Description

pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
May 29, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
NVP Healthcare
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • healthy adult subjects who signed informed consent

Exclusion Criteria

  • Subjects has a history of allergy reaction of study drug ingredient
  • Subjects participated in another clinical trial within 6 months prior to administration of the study drug
  • Inadequate subject for the clinical trial by the investigator's decision

Arms & Interventions

NVP-1203-R1 and NVP-1203-R2

Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing)

Intervention: NVP-1203-R1 and NVP-1203-R2

NVP-1203-R1

Drug: NVP-1203-R1 1 tablet, oral dosing

Intervention: NVP-1203-R1

NVP-1203-R2

Drug: NVP-1203-R2 1 tablet, oral dosing

Intervention: NVP-1203-R2

Outcomes

Primary Outcomes

Pharmacokinetic interaction

Time Frame: 0hours - 24hours

Area under the curve (AUC)

Study Sites (1)

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